Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
NCT05813223

Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough

Led by Stuart Mazzone · Updated on 2024-05-09

31

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

Sponsors

S

Stuart Mazzone

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

Recently, a new drug called Gefapixant passed phase III clinical trials for cough suppression in patients with chronic cough. The goal of this clinical trial is to investigate the effect of acute and prolonged administration of the drug Gefapixant on cough-related brain activity in patients with chronic cough. The main question it aims to answer is: does the mechanism of action of Gefapixant on the brainstem and brain circuits regulating cough differ between acute and prolonged therapy in people with chronic cough? Participants have their brain activity and their sensitivity to cough-inducing substances measured as well as complete questionnaires about their cough before and while taking daily Gefapixant.

CONDITIONS

Official Title

Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent to participate
  • Be aged 18 to 65 years
  • Be male or female
  • Non-smoker for at least 5 years
  • No history of neurological disease
  • No acute respiratory infection within the past 8 weeks
  • Have refractory or unexplained chronic cough lasting 1 year or more
  • Have a self-reported cough severity of 40 mm or higher on a 10-point scale at screening
Not Eligible

You will not qualify if you...

  • Current smoker or recreational drug user
  • Pregnant woman
  • Contraindication to MRI scanning such as metal implants or claustrophobia
  • Under 18 years old
  • Intellectual or mental impairment
  • Highly dependent on medical care
  • Dependent or unequal relationship with any research team member
  • Known allergy to chili
  • Non-English speaker

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The University of Melbourne

Parkville, Victoria, Australia, 3010

Actively Recruiting

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Research Team

S

Stuart B Mazzone, PhD

CONTACT

T

Tara G Bautista, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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